A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.

Study on the Effects of an Investigational Medication on Heart Function in Healthy Adults

Recruiting
18 years - 55 years
All
Phase 1
44 participants needed
2 Locations

Study Overview

This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cardiac Repolarization, Healthy Volunteers
  • Age: 18 years - 55 years
  • Gender: All

Inclusion Criteria:

  • Age: Healthy males and/or females aged 18 to 55 (inclusive) at consent signing.
  • Certified healthy based on history, physical exam, vitals, ECG, and labs with no abnormalities.
  • Weight: 50-100 kg (male), 40-90 kg (female); BMI 18-30 kg/m² inclusive.
  • Sex-based eligibility: All males must use effective contraception or remain abstinent and avoid sperm donation for 3 months post-dose. Females must use highly effective contraception, not be pregnant or breastfeeding, and test negative for pregnancy before treatment.

Exclusion Criteria:

  • History of significant systemic diseases (hematologic, renal, endocrine, pulmonary, GI, cardiac, hepatic, psychiatric, neurologic, infectious, allergic; except mild seasonal allergies).
  • Clinically significant ECG abnormalities.
  • Frequent headaches or migraines, and recurrent nausea or vomiting (over twice monthly).
  • Blood donation within 2 months.
  • Symptomatic or significant postural hypotension.
  • Drug hypersensitivity or significant allergies, including to study drugs.
  • History of drug/alcohol abuse.
  • Tobacco use within 3 months prior to Day 1.
  • History of Hepatitis B/C, TB, or invasive opportunistic infections.
  • Malignancy within 5 years (except treated non-metastatic skin cancer).
  • Adverse reaction to balinatunfib, moxifloxacin, or quinolones.
  • Any medication (except hormonal contraception/HRT) within 14 days or 5× half-life.
  • Biologics within 4 months prior.
  • Vaccines: non-live within 4 weeks, live within 3 months before or during study.
  • Current or recent participation in another interventional study within 30 days.
  • Positive for HBsAg, anti-HBc, anti-HCV, anti-HIV1/2.
  • Positive urine drug screen.
  • Positive alcohol breath test.
  • Positive urine cotinine test.
  • History of long QT syndrome.
  • Risk factors for TdP.
  • Moxifloxacin contraindications.
  • Low potassium (<3.5 mmol/L).
  • Low magnesium (<0.7 mmol/L).

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

This study investigates the effects of a single oral dose of an investigational medication on cardiac repolarization in healthy adults. The study is a Phase 1 trial, meaning it is an early stage of testing, and involves several different treatment arms to compare the investigational medication with a placebo and a positive control.

Participants in the study will receive a single dose of either the investigational medication, a placebo, or a positive control in a randomized, double-blind, double-dummy, crossover design. This means that neither the participants nor the researchers will know which treatment is being administered at any given time, and each participant will receive all treatments in a different sequence. The study will include procedures such as physical exams, vital signs checks, ECGs, and laboratory tests to monitor health and safety.

  • Who can participate: Healthy men and women aged 18 to 55 with a body weight within defined limits and a BMI between 18 and 30 can participate. They must use effective contraception and have no significant medical history or current conditions.
  • Study details: Participants will take a single oral dose of the investigational medication or placebo and undergo various health assessments, including ECGs and lab tests. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 10 Jan 2026. Study ID: NCT07272629

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